Recurrent Vulvovaginal CandidiasisPhase 3NCT05074602
A Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Recurrent Vulvovaginal Candidiasis
A Phase 3 study testing SHR8008 and Fluconazole in people with Recurrent Vulvovaginal Candidiasis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 capsule In Subjects With Recurrent Vulvovaginal Candidiasis Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Recurrent Vulvovaginal Candidiasis
- What is being tested?
- SHR8008 and Fluconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2021to 30 Sep 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females, ≥18 and ≤75 years old.
- Have a history of RVVC at screening.
- Suitable for oral therapy and able to swallow capsules intact.
- Subjects of childbearing potential must use highly effective contraceptive measures throughout the study.
- Willing to sign the informed consent form to participate in this study.
Who cannot join
- Presence of concomitant vulvovaginitis caused by other pathogens.
- Have a history of cervical cancer, or "cervical intraepithelial neoplasia or malignancy" or "atypical squamous cells of undetermined significance (ASCUS)" as indicated by Pap test or other tests reported within 1 year before screening (not applicable to subjects with a history of total hysterectomy).
- Any condition that, in the opinion of the investigator, could impact drug absorption, distribution, or elimination.
- Moderate to severe hepatic and/or renal disorders.
- Significant laboratory abnormality at screening.
- QTc interval greater than 470 ms or other clinically significant ECG abnormality at screening.
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- Have received systemic or vulvovaginal antifungal drugs, antibacterials, antitrichomonal, CYP3A4 substrates or inducers or inhibitors, and vulvovaginal corticosteroids within 7 days prior to randomization.
- Have received any estrogen replacement therapy or vaginal topical products.
- Have received systemic corticosteroid therapy within 30 days or systemic immunosuppressant therapy within 90 days prior to randomization;
- Have planned surgery or other medical procedures that may impact compliance with the protocol;
- Known history of hypersensitivity or intolerance to azole antifungal drugs.
- History of narcotic or drug abuse or alcoholism, or any other medical, psychiatric or social condition that in the investigator's opinion could preclude compliance with the protocol.
- Women who are pregnant or lactating, or planning to become pregnant during the study period.
- Have received VT-1161 study medication in a previous study or received any investigational medicinal product (IMP) in a clinical study within 5 half-lives of that IMP prior to screening (if the half-life is unknown, 60 days prior to screening);
- other conditions unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
Jinghe Lang, Bachelor, +86-10-69156699, langjh@hotmail.com
About this study
Official title: A Randomized, Double-Blind, Double-Dummy, Parallel Fluconazole Controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Recurrent Vulvovaginal Candidiasis (RVVC)
The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 capsule In Subjects With Recurrent Vulvovaginal Candidiasis
- Conditions
- Recurrent Vulvovaginal Candidiasis
- Being tested
- SHR8008, Fluconazole
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR8008Drug
Dosing frequency: During Part 1, administered orally once daily for 2 days. During Part 2, administered orally once weekly for 11 weeks starting from Week 3, Route of administration: oral
FluconazoleDrug
Dosing frequency: During Part 1, administered orally 3 sequential doses (every 72 hours), During Part 2, administered orally once weekly for 6 Months starting from Week 3. Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| SHR8008 | Experimental | Not described Receives: Drug: SHR8008 |
| Fluconazole | Active comparator | Not described Receives: Drug: Fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with one or more culture-verified VVC episodes during the study.
Measured: 50 weeks
Secondary outcomes (17)
The proportion of subjects with resolved VVC episode (clinical signs and symptoms score of < 3) during induction phase
Measured: Day 14
The proportion of subjects with 2 culture-verified VVC episodes during the study.
Measured: week 50
The proportion of subjects with ≥ 3 culture-verified VVC episodes during the study.
Measured: week 50
The proportion of subjects with one or more culture-verified VVC episodes during the maintenance phase and follow-up phase.
Measured: Week 3 through Week 50
Time to first recurrence of a culture-verified VVC episode during the maintenance phase and follow-up phase.
Measured: Week 3 through Week 50
The proportion of subjects with at least one positive culture for Candida species during the maintenance phase and follow-up phase
Measured: Week 3 through Week 50
The proportion of subjects receiving rescue treatment during the maintenance phase and follow-up phase.
Measured: Week 3 through Week 50
The proportion of subjects with clinical cure (defined as the absence of all signs and symptoms of VVC) at the end of induction phase .
Measured: Day 14
The proportion of subjects with mycological cure (defined as vaginal swab culture negative for growth of Candida species) at the end of induction phase.
Measured: Day 14
The proportion of subjects with therapeutic cure (clinical cure plus mycological cure) at the end of induction phase.
Measured: Day 14
The proportion of subjects with therapeutic cure, clinical cure, and mycological cure during the maintenance phase.
Measured: Day 14
The proportion of subjects with one or more culture-verified VVC episode during the maintenance phase
Measured: Week 3 through Week 13
The proportion of subjects with at least one positive culture for Candida species during the maintenance phase
Measured: Week 3 through Week 13
The proportion of subjects with one or more culture-verified VVC episode during the maintenance phase
Measured: Week 3 through Week 26
The proportion of subjects with at least one positive culture for Candida species during the maintenance phase
Measured: Week 3 through Week 26
The proportion of subjects with one or more culture-verified VVC episodes during the follow-up phase.
Measured: Week 27 through Week 50
The proportion of subjects with at least one positive culture for Candida species during the follow-up phase
Measured: Week 27 through Week 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start14 Sep 2021
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Vulvovaginal CandidiasisStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized, Double-Blind, active controlled, parallel groups, Multicenter Phase III Clinical Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074602
- Sponsor's protocol ID
- SHR8008-301
- Status last verified
- Sep 2021
- First submitted
- 29 Sep 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Double-Dummy, Parallel Fluconazole Controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole in Subjects With Recurrent Vulvovaginal Candidiasis (RVVC)
- ClinicalTrials.gov ID
- NCT05074602
- Acronym / sponsor ID
- SHR8008-301
- Conditions
- Recurrent Vulvovaginal Candidiasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 capsule In Subjects With Recurrent Vulvovaginal Candidiasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Randomized, Double-Blind, active controlled, parallel groups, Multicenter Phase III Clinical Study
| Arm | Type | Receives |
|---|---|---|
| SHR8008 | Experimental | Drug: SHR8008 |
| Fluconazole | Active comparator | Drug: Fluconazole |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Females, ≥18 and ≤75 years old.
- Have a history of RVVC at screening.
- Suitable for oral therapy and able to swallow capsules intact.
- Subjects of childbearing potential must use highly effective contraceptive measures throughout the study.
- Willing to sign the informed consent form to participate in this study.
Key exclusion criteria (15 listed)
- Presence of concomitant vulvovaginitis caused by other pathogens.
- Have a history of cervical cancer, or "cervical intraepithelial neoplasia or malignancy" or "atypical squamous cells of undetermined significance (ASCUS)" as indicated by Pap test or other tests reported within 1 year before screening (not applicable to subjects with a history of total hysterectomy).
- Any condition that, in the opinion of the investigator, could impact drug absorption, distribution, or elimination.
- Moderate to severe hepatic and/or renal disorders.
- Significant laboratory abnormality at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR8008Dosing frequency: During Part 1, administered orally once daily for 2 days. During Part 2, administered orally once weekly for 11 weeks starting from Week 3, Route of administration: oral | Drug | SHR8008 |
| FluconazoleDosing frequency: During Part 1, administered orally 3 sequential doses (every 72 hours), During Part 2, administered orally once weekly for 6 Months starting from Week 3. Route of administration: oral | Drug | Fluconazole |
Primary outcome
The proportion of subjects with one or more culture-verified VVC episodes during the study.
Time frame: 50 weeks
17 secondary outcomes
The proportion of subjects with resolved VVC episode (clinical signs and symptoms score of < 3) during induction phase
Time frame: Day 14
The proportion of subjects with 2 culture-verified VVC episodes during the study.
Time frame: week 50
The proportion of subjects with ≥ 3 culture-verified VVC episodes during the study.
Time frame: week 50
The proportion of subjects with one or more culture-verified VVC episodes during the maintenance phase and follow-up phase.
Time frame: Week 3 through Week 50
Time to first recurrence of a culture-verified VVC episode during the maintenance phase and follow-up phase.
Time frame: Week 3 through Week 50
The proportion of subjects with at least one positive culture for Candida species during the maintenance phase and follow-up phase
Time frame: Week 3 through Week 50
The proportion of subjects receiving rescue treatment during the maintenance phase and follow-up phase.
Time frame: Week 3 through Week 50
The proportion of subjects with clinical cure (defined as the absence of all signs and symptoms of VVC) at the end of induction phase .
Time frame: Day 14
The proportion of subjects with mycological cure (defined as vaginal swab culture negative for growth of Candida species) at the end of induction phase.
Time frame: Day 14
The proportion of subjects with therapeutic cure (clinical cure plus mycological cure) at the end of induction phase.
Time frame: Day 14
The proportion of subjects with therapeutic cure, clinical cure, and mycological cure during the maintenance phase.
Time frame: Day 14
The proportion of subjects with one or more culture-verified VVC episode during the maintenance phase
Time frame: Week 3 through Week 13
The proportion of subjects with at least one positive culture for Candida species during the maintenance phase
Time frame: Week 3 through Week 13
The proportion of subjects with one or more culture-verified VVC episode during the maintenance phase
Time frame: Week 3 through Week 26
The proportion of subjects with at least one positive culture for Candida species during the maintenance phase
Time frame: Week 3 through Week 26
The proportion of subjects with one or more culture-verified VVC episodes during the follow-up phase.
Time frame: Week 27 through Week 50
The proportion of subjects with at least one positive culture for Candida species during the follow-up phase
Time frame: Week 27 through Week 50
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SHR8008 and Fluconazole in people with Recurrent Vulvovaginal Candidiasis, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yong Cao, M.D (+0518-81220121, yong.cao@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects with one or more culture-verified VVC episodes during the study. (time frame: 50 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.